Complete FDA and NHTSA recall records dated in December 2023.
These records include useful source details for the selected month.
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a…
Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a…
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic…
One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have…
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic…
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a…
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were…
Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were…
RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a…
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a…
RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a…
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to…
CARDIOHELP-i System was not properly tested to measure leakage current
One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have…
The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its…
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic…
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of…
Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
